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Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Primary Purpose

Bacterial Infections and Mycoses, Appendicitis, Cholecystitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Doripenem
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections and Mycoses focused on measuring Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis, Peritonitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has a requirement for surgical intervention within 24 hours of study entry Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections. Exclusion Criteria: Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control Any rapidly-progressing disease or immediately life-threatening illness.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clinical response rate measured at late follow-up visit.

    Secondary Outcome Measures

    Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests results) conducted throughout the study.

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Peninsula Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00210938
    Brief Title
    Doripenem in the Treatment of Complicated Intra-Abdominal Infections
    Official Title
    A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    Peninsula Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infections.
    Detailed Description
    Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of intravenous doripenem versus a comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. The primary endpoint is the clinical response rate measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis, Peritonitis
    Keywords
    Complicated Intra-Abdominal Infections, Appendicitis, Cholecystitis, Peritonitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    478 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Doripenem
    Primary Outcome Measure Information:
    Title
    Clinical response rate measured at late follow-up visit.
    Secondary Outcome Measure Information:
    Title
    Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests results) conducted throughout the study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Has a requirement for surgical intervention within 24 hours of study entry Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections. Exclusion Criteria: Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control Any rapidly-progressing disease or immediately life-threatening illness.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20211892
    Citation
    Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8.
    Results Reference
    derived
    PubMed Identifier
    19670912
    Citation
    Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001.
    Results Reference
    derived
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=637&filename=CR005383_CSR.pdf
    Description
    A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Meropenem in Complicated Intra-abdominal Infections

    Learn more about this trial

    Doripenem in the Treatment of Complicated Intra-Abdominal Infections

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